AU2009261685A1

AU2009261685A1 - Wounddressing and headgear

Info

Publication number: AU2009261685A1
Application number: AU2009261685A
Authority: AU
Inventors: Jake Timothy
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-06-18
Filing date: 2009-06-17
Publication date: 2009-12-23
Anticipated expiration: 2029-06-17
Also published as: KR101459745B1; GB2461048A; KR20110042270A; EP2293749A1; CN102083398B; RU2010151858A; CA2728157C; CA2728157A1; GB0811136D0; AU2009261685B2; US8481804B2; JP2011524768A; RU2504355C2; MY159462A; BRPI0914844A2; IL210050A; US20110144555A1; WO2009153594A1; ZA201100372B; GB2461048B

Description

WO 2009/153594 PCT/GB2009/050688 1 WOUNDDRESSING AND HEADGEAR The present invention relates to a wound dressing, in particular, to an improved wound dressing for reducing post-operative swelling of a body 5 part of a human or animal patient, or for controlling blood loss from wounds. The invention also relates to a method for reducing post-operative swelling of a body member of a human or animal patient, or for controlling blood 10 loss from wounds. Post-operative swelling results from the accumulation of bodily fluid around an operation wound. Post-operative swelling cannot be eliminated altogether because following an operation the wound needs a blood 15 supply to enable healing which inevitably results in some leakage and, hence, swelling. Since swelling can hinder recovery and in some cases lead to further complications, it is always an issue that is sought to be minimised. 20 The control of blood loss, especially following a serious accident, is of great importance as excessive loss of blood can hamper recovery leading to medical complications or even fatality. 25 The use of bandages is known in the art in order to minimise post operative swelling or to control blood loss. The use of bandages is appealing since they are generally versatile in that they can be readily adapted for use on different body members and on wounds of different sizes. 30 WO 2009/153594 PCT/GB2009/050688 2 However when used as an aid for minimising post-operative swelling, bandages can be bulky and cumbersome. This is especially the case in relation to head injuries where most of the bandage employed does not come into contact with the wound but rather is around the head merely 5 holding a small part of the bandage against the wound. Moreover, wounds need to be checked periodically, to ensure that there is not excessive leakage of fluid from the wound. Generally, bandages are disposed of when a wound is checked and this is wasteful. 10 There are a number of devices known in the art directed at minimising post-operative swelling in patients undergoing surgery on the head. W02005/097022 discloses a post-operative head dressing comprising a rigid cap adapted to fit over the head of a patient, and a liner. The liner is 15 a network of tubes of resilient material connected to a single opening through which gas may be introduced to pressurise the liner network. The liner expands against the cap to squeeze the head. GB 2435833 discloses a post-operative head dressing comprising a cap 20 adapted to fit over the head of a patient. The cap is a patchwork of compartments of airtight flexible material which are evacuated during use, whereby atmospheric pressure compresses the flexible material. The compartments are filled with beads, preferably polystyrene beads, so that, on air evacuation, the cap not only becomes rigid, but also gently pressed 25 against the scalp to inhibit post-operative swelling and/or bleeding from head wounds. According to a first aspect of the invention there is provided a wound dressing comprising a sealed enclosure having at least one compartment; 30 a plurality of spaced apart pillar-like structures positioned within the at WO 2009/153594 PCT/GB2009/050688 3 least one compartment; and means for evacuating air from the at least one compartment, wherein the evacuation of air from the at least one compartment causes a reduction in the distance between at least two of the pillar-like structures. 5 The reduction in the distance between at least two of the pillar-like structures has the effect of reducing the overall length of the bandage resulting in the exertion of pressure by the dressing to the wound in use thus restricting the amount of swelling that may occur. The present 10 invention thus provides an improved wound dressing that stems swelling and bleeding of a wound. The pillar-like structures may be formed from any suitable material. Ideally the pillar-like structures are formed from either a rubber based material, a 15 silicon based material or an elastomeric polymer. Preferably the pillar-like structures are spaced apart from each other in a predetermined arrangement. 20 By arranging the pillar-like structures in a predetermined arrangement, the way in which pressure can be exerted onto a body member when air is evacuated from the compartment can be controlled. For example, arrangement of the pillar-like structures in long thin parallel strips will result in greater reduction along one axis than another. 25 Conveniently the pillar-like structures are evenly spaced within the compartment. By having the pillar-like structures evenly spaced from each other, an equal reduction in the distance between adjoining pillar-like structures will take place, hence resulting in the application of uniform WO 2009/153594 PCT/GB2009/050688 4 pressure across a body part once air has been evacuated from the compartment. Preferably the pillar-like structures are cylindrical columns, however, the 5 pillar-like structures may be formed of columns having any suitable cross sectional geometry. For example, the pillar-like structures could be triangular, rectangular, hexagonal etc in cross-section. Advantageously each pillar-like structure is connected to a neighbouring 10 pillar-like structure by a connecting member in order to define a lattice-like structure. Connecting the pillar-like structures to a neighbouring structure removes the need for re-adjusting the positions of the structures relative to each 15 other after use, as is generally required in the prior art dressings mentioned above that incorporate bead structures. The connecting members may be integrally formed with the pillar-like structures. Alternatively the connecting members may be bonded with the 20 pillar-like structures. Preferably the sealed enclosure comprises a first and second film layer. The first and second film layers may be formed of any suitable material. 25 Ideally the first and second film layers are formed from a vacuum formable material such as PVC. Preferably the first and second film layers are bonded together around their edges to define the sealed enclosure. The pillar-like structures are 30 thus retained between the first and second film layers WO 2009/153594 PCT/GB2009/050688 5 The first and second film layers may be bonded together by any suitable means, for example the film layers may be heat sealed, ultrasonically welded or glued together. 5 Preferably the plurality of pillar-like structures are moveably retained between the first and second film layers. Preferably the plurality of pillar-like structures are retained in position 10 between the first and second film layers by connection to the first and/or second film layer. The pillar-like structures may be retained in position between the first and second film layers by any suitable means, for example by a heat seal, an 15 ultrasonic weld or glue. Preferably the plurality of pillar-like structures are integrally formed with at least one of the film layers. 20 Preferably a portion of the first film layer is adapted to be drawn into the space between the at least two pillar-like structures when air is evacuated from the compartment. As the first film layer is drawn into the space the dimensions of the wound dressing are reduced, causing a reduction in the distance between the at least two pillar-like structures. 25 Preferably the wound dressing further comprises a frame portion for attaching the dressing to a head of a patient. Conveniently the frame portion comprises a securing band for securing the 30 dressing onto the head of a patient.

WO 2009/153594 PCT/GB2009/050688 6 Preferably the frame portion comprises means for adjusting the working length of the securing band. 5 The means for adjusting the working length of the securing band allows the wound dressing to be used with different size heads. Preferably the means for adjusting the working length of the securing band comprises a pawl and ratchet mechanism. 10 The pawl and ratchet mechanism may be a self limiting pawl and ratchet mechanism of the type known in the art. Preferably the means for adjusting the size of the securing band 15 comprises a clip adjuster. Preferably the frame portion further comprises a retaining member which is adapted, in use, to restrict the removal of the wound dressing independently of the securing band. 20 Preferably the frame portion comprises a flexible plastic material. The flexible plastic material is preferably a thermoplastic material, ideally an acrylonitrile butadiene styrene (ABS) or a polypropene (PB). 25 Preferably the means for evacuating air from the at least one compartment comprises a vacuum release valve. The means for evacuating air from the at least one compartment may 30 further comprise a non-return valve in order to prevent the regression of WO 2009/153594 PCT/GB2009/050688 7 air into the at least one compartment during the evacuation of air from the compartment. Preferably the wound dressing further comprises means for introducing air 5 into the at least one compartment. The means for introducing air into the at least one compartment may be in the form of a hand pump or an inlet valve connectable to a compressor. According to a second aspect of the invention there is provided a method 10 of reducing post-operative swelling of a body member of a human or animal patient, or for controlling blood loss from wounds comprising the steps of: a) applying to the body member or wound a dressing formed by a 15 sealed enclosure having at least one compartment and a plurality of spaced apart pillar-like structures; and b) applying pressure onto the body member or wound by reducing the spacing between at least one pair of pillar-like structures by 20 evacuating the at least one compartment of air. According to a third aspect of the invention there is provided a headgear comprising a head covering portion and a frame portion comprising a securing band, wherein the frame portion further comprises at least one 25 retaining member positioned on a side of the headgear which, in use, restricts the removal of the headgear independently of the securing band. The third aspect of the invention thus enables a headgear to be secured on the head of a user without the need of a chin strap as securement of WO 2009/153594 PCT/GB2009/050688 8 the headgear will be provided by the securing band and the at least on retaining member. There now follows a description of preferred embodiments of the 5 invention, by way of non-limiting example, with reference being made to the accompanying drawings, in which: Figure 1 is a plan view of a first embodiment of a wound dressing according to the invention; 10 Figure 2 is a cross-sectional view of the wound dressing of Figure 1 taken along line A-A in Figure 1; Figure 3a is a schematic view of a section of the wound dressing of Figure 15 1 showing the spacing between two pillar-like structures prior to evacuation of air from the compartment; Figure 3b is a schematic view of the section shown in Figure 3a following the evacuation of air from compartment; 20 Figure 4 is a schematic view showing the application of a wound dressing according to the invention applied to an arm of a patient; Figure 5 is a perspective view of a second embodiment of a wound 25 dressing according to the invention in the form of a head wound dressing; and Figure 6 is a partial side rear view of the wound dressing of Figure 5.

WO 2009/153594 PCT/GB2009/050688 9 Referring to Figures 1 and 2, a first embodiment of a wound dressing (10) according to the invention is shown. The wound dressing (10) comprises a sealed enclosure (12) having at least one compartment (14); a plurality of spaced apart pillar-like structures (16) positioned within the at least one 5 compartment (14); and means for evacuating air from the at least one compartment (not shown). The sealed enclosure (12) comprises a first film layer (22) and a second film layer (24) which are sealed together around their edges to define the 10 sealed enclosure (12). The first and second film layers (22, 24) may additionally be bonded together at various points in order to define one or more further compartments within the sealed enclosure (12). The first and second film layers (22, 24) are made of PVC material and are 15 heat sealed to one another to define the sealed enclosure (12) and/or compartments. The pillar-like structures (16) (hereinafter referred to as 'pillars') are substantially cylindrical in shape and are connected to a neighbouring 20 structure by means of a connecting member (26). In this arrangement the pillars (16) and the connecting members (26) define a lattice-like structure. In a preferred embodiment, the pillars are made from a silicon based material and the connecting members (26) are made of a resilient material such as a flexible plastic material. 25 The pillars (16) may be moveably retained between the first and second film layers (22, 24) or may be retained in position between the film layers (22, 24) by connection to the first and/or second film layer.

WO 2009/153594 PCT/GB2009/050688 10 The means for evacuating air from the at least one compartment is in the form of a vacuum release valve (not shown) having a non-return valve in order to prevent regression of air into the at least one compartment during evacuation of air from the compartment (14). 5 Referring to Figures 3a and 3b, when air is evacuated from the compartment (14), a portion of the first film layer (22) and a portion of the second film layer (24) are pulled into the space (20) between two adjoining pillars (16) (as best seen in Figure 3b). As the film layers (22, 24) are 10 pulled into the space (20) by the vacuum left by the evacuation of air therefrom, the overall surface area of the wound dressing (10) is reduced causing a reduction in the spacing between the adjoining pillars (16). As the adjoining pillars (16) are drawn towards one another, the 15 connecting members (26) are caused to flex inwardly into the space (20). The film layers (22, 24) provide a controlled and self-limiting decrease in length of the wound dressing (10) in one or two axis as air is expelled. 20 When air is reintroduced into the compartment (14), the pillars (16) are returned to their original spacing due to the resiliency of the connecting members (26) causing the connecting members (26) to straighten and hence push the pillars (16) away from each other. 25 The pillars (16) are spaced apart from each other in a predetermined arrangement depending on requirements. That is to say the shape and spacing of the lattice elements (i.e. the pillars (16) and connecting members (26)) will determine how the wound dressing (10) changes when a vacuum is applied. For example, if the pillars (16) are arranged in a WO 2009/153594 PCT/GB2009/050688 11 series of long thin strips that are parallel to one another there will be a greater reduction along the transverse axis than the longitudinal axis. The wound dressing (10) further comprises means for introducing air into 5 the at least one compartment (not shown) which may be in the form of a hand pump or an inlet valve connectable to a compressor. Referring to Figure 4, a wound dressing according to a first embodiment of the invention is shown applied to an arm of a patient in order to reduce 10 post-operative swelling of the arm of a patient. The wound dressing is first positioned around the post-operative wound and secured in place by a suitable means such as a band, a strap, VELCRO®, tape or the like. Pressure is then applied onto the body 15 member to constrict swelling of the body member by evacuating the at least one compartment of air. As described above, evacuation of air results in the film layers (22, 24) being pulled down into the space (20) between the pillars (16) results in the pulling of the pillars (16) closer together and a reduction of the overall dimensions of the wound dressing 20 (10). Referring to Figure 5, a second embodiment of a wound dressing according to the invention is shown. The wound dressing (100) is in the form of a head wound dressing and comprises a head covering portion 25 (102) and a frame portion (104) for attaching the dressing to a head of a patient. The head covering portion (102) is a similar construction to the wound dressing (10) described above and the same reference numerals have 30 been used to identify identical features.

WO 2009/153594 PCT/GB2009/050688 12 The frame portion (104) comprises a securing band (106) for securing the dressing (100) to the head of a patient and a pair of restraining members (114) positioned on opposite sides of the dressing (100) and located so as 5 to be positioned on either side of a patient's head when worn. The components of the frame portion (104) are produced from a flexible plastic in order to allow them to conform comfortably around the head whilst being rigid enough not to stretch and allow the wound dressing 10 (100) to be able to be unwilling pulled off the head. The securing band (106) is adapted to run circumferentially around the head of a patient. In the embodiment shown, the securing band (106) comprises two band members (108) each adapted to run from the 15 forehead of user, along the temple and down such that it finishes below the occipital lobe to provide a secure hold. The frame portion (104) further comprises means for adjusting the active length of the securing band (106). In the embodiment shown, the dressing 20 (100) comprises a first means for adjusting the active length of the securing band (106) located at the front of the wound dressing (100) and a second means for adjusting the active length of the securing band (106) located at the rear of the wound dressing (100). 25 The front adjusting means is a pawl and ratchet mechanism (110) coupled to a first end of the two band members (108). The pawl and ratchet mechanism includes a knob (126) for adjusting the tension of a frontal section of the securing band (106).

WO 2009/153594 PCT/GB2009/050688 13 Referring to Figure 6, the rear adjusting means is a clip adjuster (112) of a kind similar to that known in the art. The clip adjuster (112) comprises a plurality of eyelets (118) positioned proximate a second end of each band member (108). The eyelets (118) are adapted to receive a corresponding 5 projection (120) located on a mounting member (122). The number of eyelets (118) and corresponding projections (120) determine the number of adjustment positions that may employed to increase the tension of a rearward section of the securing band (106). In the embodiment shown each band member (108) comprises four eyelets (118). As shown in 10 Figure 6, the mounting member (122) may incorporate a plurality of receiving loops (124) in which the ends of the band members (118) may be securely tucked away. Each restraining member (114) is adapted to fit around an ear of a user. 15 In the embodiment shown, a first end of the restraining member (114) is connected to the securing band (106) at a location proximate a front end of the wound dressing (100) and a second end is connected to securing band (106) proximate the rear end of the wound dressing (100). 20 The restraining members (114) act to restrict the removal of the headgear independently of the securing band (106) and together with the securing band (106) allow the wound dressing (100) to be secured on the head without the use of a chin strap or obscuring the ears. 25 While the frame structure of the wound dressing (100) has been described with particular reference to use in a headgear for use in reducing post operative swelling of a head wound, or for controlling blood loss from head wounds, the unique frame structure described above may be incorporated in a headgear where securement of the headgear to the head of a user is 30 required. For example the frame structure may be incorporated into a WO 2009/153594 PCT/GB2009/050688 14 safety or protective helmet in order to provide a helmet without a chin strap. All of the features disclosed in this specification (including any 5 accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. 10 Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar 15 features. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying 20 claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. A wound dressing comprising a sealed enclosure having at least one compartment; a plurality of spaced apart pillar-like structures 5 positioned within the at least one compartment; and means for evacuating air from the at least one compartment, wherein the evacuation of air from the at least one compartment causes a reduction in the distance between at least two of the pillar-like structures. 10

2. A wound dressing according to Claim 1 wherein the pillar-like structures are evenly spaced within the compartment.

3. A wound dressing according to anyone of the preceding claims wherein the pillar-like structures are cylindrical columns. 15

4. A wound dressing according to anyone of the preceding claims wherein each pillar-like structure is connected to a neighbouring pillar-like structure by a connecting member in order to define a lattice-like structure. 20

5. A wound dressing according to any one of the preceding claims wherein the sealed enclosure comprises a first and second film layer.

6. A wound dressing according Claim 5 wherein the first and second film layers are bonded together around their edges to define the sealed 25 enclosure.

7 A wound dressing according to Claim 5 or 6 wherein the plurality of pillar-like structures are moveably retained between the first and second film layers. 30 WO 2009/153594 PCT/GB2009/050688 16

8. A wound dressing according to Claim 5 or 6 wherein the plurality of pillar-like structures are retained in position between the first and second film layers by connection to the first and/or second film layer. 5

9. A wound dressing according to Claims 5 or 6 wherein the plurality of pillar-like structures are integrally with at least one of the film layers.

10 A wound dressing according to any one of Claims 5 to 9 wherein a portion of the first film layer is adapted to be pulled into the space between 10 the at least two pillar-like structure to the reduce the distance between the at least two pillar-like structure.

11. A wound dressing according to anyone of the preceding claims further comprising a frame portion for attaching the dressing to a head of a 15 patient,

12. A wound dressing according to Claim 11 wherein the frame portion comprises a securing band for securing the dressing onto the head of a patient. 20

13, A wound dressing according to Claim 12 wherein the frame portion comprises means for adjusting the working length of the securing band.

14, A wound dressing according to Claim 13 wherein the means for 25 adjusting the working length of the securing band comprises a pawl and ratchet mechanism.

15, A wound dressing according to Claim 13 or 14 wherein the means for adjusting the size of the securing band comprises a clip adjuster. 30 WO 2009/153594 PCT/GB2009/050688 17

16. A wound dressing according to any one of Claims 11 to 15 wherein the frame portion further comprises a restraining member.

17, A wound dressing according to anyone of Claims 11 to 16 wherein 5 the frame portion comprises a flexible plastic material.

18. A method of reducing post-operative swelling of a body member of a human or animal patient, or for controlling blood loss from wounds comprising the steps of: 10 a) applying to the body member or wound a dressing formed by a sealed enclosure having at least one compartment and a plurality of spaced apart pillar-like structures; and 15 b) applying pressure onto the body member or wound by reducing the spacing between at least one pair of pillar-like structures by evacuating the at least one compartment of air.

19. A method as claimed in Claim 17 wherein the dressing is a dressing 20 according to any one of Claims 1 to 16.

20. A headgear comprising a head covering portion and a frame portion comprising a securing band, wherein the frame portion further comprises at least one retaining member positioned on a side of the headgear which, 25 in use, restricts the removal of the headgear independently of the securing band.

21. A wound dressing as hereinbefore described with reference to and/or illustrated in the accompanying drawings. 30 WO 2009/153594 PCT/GB2009/050688 18

22. A method of reducing post-operative swelling of a body member of a human or animal patient, or for controlling blood loss from wounds as hereinbefore described with reference to and/or illustrated in the accompanying drawings. 5

23. A headgear as hereinbefore described with reference to and/or illustrated in the accompanying drawings.